FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for catheter defects and connector detachment risk

OTHERNationwide distributionMedical devices

What this means

Medline identified quality issues in several medical procedure kit models during an internal review. The kits contained catheters with surface irregularities, connectors that could detach prematurely from the catheter funnel, and in some cases catheters with dimensions outside acceptable specifications.

  • Check your Medline kit against the recalled lot numbers and SKU numbers listed in the FDA notice.
  • Do not use recalled kits. Contact your healthcare facility or supplier about replacement.
  • Report any adverse events or injuries related to these kits to the FDA MedWatch program.
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The agency's original wording
Hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
1432 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2496-2026

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